| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22024 |
| Drug | Enfortumab vedotin |
| Brand | Padcev® |
| Indication | As monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor |
| Assessment Process | |
| Rapid review commissioned | 22/04/2022 |
| Rapid review completed | 18/05/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of enfortumab vedotin (Padcev®) compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 27/05/2022 |
| Pre-submission consultation with Applicant | 19/07/2022 |
| Full submission received from Applicant | 23/11/2022 |
| Preliminary review sent to Applicant | 16/03/2023 |
| NCPE assessment re-commenced | 17/04/2023 |
| Factual accuracy sent to Applicant | 21/06/2023 |
| NCPE assessment re-commenced | 28/06/2023 |
| NCPE assessment completed | 12/07/2023 |
| NCPE assessment outcome | The NCPE recommends that enfortumab vedotin (Padcev®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
